1. Field of the Invention
[The starting point of the present invention is represented by an arrangement according to the preamble of claim 1. Such an arrangement is described in U.S. Pat. No. 4,212,304.] The invention relates to an arrangement for the insertion of a ureter tube into the ureter or renal pelvis comprising a ureter tube, an auxiliary tube and a movable mandrin.
2. Description of the Related Art
An arrangement comprising a ureter tube, an auxiliary tube and a mandrin is described in U.S. Pat. No. 4,212,304.
With such an arrangement, it is possible to insert the ureter tube into the ureter with the aid of a massive mandrin. After removal of the massive mandrin the arrangement remains in the ureter because of an inherent curvature in the form of a hook at both ends (also called "memory") at the renal pelvis and the inner wall of the bladder. However, the introduction of an X-ray contrast [media] medium into the ureter was not possible. The necessary X-ray contrast media had to be introduced first into the ureter by separate measures before the ureter tube could be introduced. Such a procedure of introducing an arrangement twice is time-consuming for the physician and troublesome for the patient.
It is an object of this invention to improve the arrangement as described in U.S. Pat. No. 4,212,304 in such a way that the introduction of an X-ray contrast [media] medium can be carried out faster and simpler for the patient and by requiring less actions by the physician.
[It has been found that starting with the arrangement according to the preamble of claim 1, such an object can be achieved by using] It has been found that such an improved arrangement for the insertion of a ureter tube into the ureter or renal pelvis comprising a ureter tube, an auxiliary tube and a mandrin, each having an upper or distal and a lower or proximal end and a mandrin, which mandrin is movable in longitudinal direction relative to the ureter tube and the auxiliary tube, and the auxiliary tube and the ureter tube are slidable over the mandrin, can be achieved if the mandrin of the arrangement is a hollow mandrin, in which the cross-section of the hollow space inside of the mandrin is open for the injection of an X-ray medium, the hollow space inside of the mandrin has in the section of its upper (distal) tip at least one outlet opening for the passage of an X-ray contrast medium which outlet opening has an entry to the ureter, and if the hollow space inside of the mandrin has at its other (proximal) end, projecting from the auxiliary tube, a connecting-piece or opening for the introduction of the X-ray contrast medium, and if the ureter tube has a front-side opening at its upper (distal) tip. In the arrangement, it is of advantage to use a hollow single mandrin, i.e. a mandrin with a hollow space inside of it. The cross-section of the hollow space inside of the mandrin is, throughout its length, [always] open for the injection of X-ray contrast media, and has in the area of its upper (distal) tip or end at least one opening or outlet for the passage of X-ray contrast media. The opening - preferably by a front-face opening of the tip of the ureter tube - has an entry to the ureter. The hollow space inside of the mandrin has, at its other (proximal) end, [a connection or opening for introducing an X-ray contrast media (claim 1) projecting over the auxiliary tube.] projecting over the auxiliary tube, a connecting-piece or opening for introducing an X-ray contrast medium. The hollow space inside the mandrin provides a sufficiently large through hole for the passage of an X-ray contrast media. A physician can permanently introduce an X-ray contrast media into the ureter during the insertion of the ureter tube, auxiliary tube and the single hollow mandrin which stiffens the ureter tube. The position of the ureter tube and in particular of its distal tip can be controlled via X-ray radioscopy during the insertion procedure. The advantages for both the physician and the patient are the shortening of the insertion procedure as well as a lower number of manipulations that are endured by the patient.
A [proximal] distal opening of the tip of the ureter tube is described in the German Utility Model 9,0 15,815. This [proximal] distal opening is described only in connection with, inter alia, a double mandrin. [The present invention, on the other hand, concerns a single mandrin as claimed in claim 1.]
[Furthermore, the invention starts from an arrangement as given in the preamble of claim 2 which is particularly suitable for the insertion of the ureter tube and its execution by the physician. Such an arrangement is described with a double mandrin in German Utility Model 90 15,815.] In an embodiment of the described arrangement, it is possible to inject X-ray contrast [media] medium through the inner hollow-cylindrical cavity of the outer mandrin and the central opening at the [face] front-side of the upper (distal) tip of the ureter tube into the ureter, after pulling out the inner mandrin, whereby an X-ray contrast [media] medium can reach the renal pelvis.
Here and in the following description, the term upper tip of the ureter tube shall refer to the [proximal] distal end of the ureter tube which is inserted into the ureter. The term tip of the mandrin resp. inner mandrin shall refer to the [proximal] distal end of the mandrin resp. inner mandrin which is directed toward the patient.
Though the [described] arrangement described in German Utility Model 90 15 815 represented an essential improvement of the then existing prior art, e.g. as described in U.S. Pat. No. 4,212,304, it had a disadvantage in that the physician has to pull out the inner mandrin from the ureter tube respectively the outer mandrin first before an X-ray contrast [media] medium could be introduced, and then has to reinsert the inner mandrin again into the outer mandrin in order to stiffen and to straighten the inherent curvature of the tip of the ureter tube. These are two time-wasting steps for the physician which risks the danger of an undesired migration of the position of the ureter tube, as well as incurring unpleasant and time-consuming manipulations for the patient.
As alternative embodiment, German Utility Model 9,015,815 discloses enlarging the lumen, i.e. the cylindrical space between the inner mandrin and the outer mandrin, to such a degree, that when the inner mandrin is not pulled out, the X-ray contrast [media] medium can be introduced via the enlarged lumen and via the central side opening of the tip of the ureter tube into the ureter or into the renal pelvis. This alternative embodiment, however, has a disadvantage in that the production costs of such equipment increases due to the necessity of a reproducible and reliable precision of manufacturing a lumen of such dimensions. A further disadvantage is that there is not much room, with respect to the cross-section difference, for the lumen to allow the flow of an X-ray contrast media. Hence, the X-ray contrast media must be injected with very high pressure. This is so because the outer diameter of the ureter tube must not exceed a certain size.
[According to the preamble of claim 2,] In one embodiment of an arrangement according to this invention a double mandrin with an outer mandrin and a hollow inner mandrin can be used. The inner mandrin is movable in longitudinal direction relative to the outer mandrin and the ureter tube and auxiliary tube are slidable over the double mandrin. The hollow space inside of the inner mandrin has in the section of its upper (distal) tip at least one upper outlet opening for the passage of X-ray contrast medium and at its other (proximal) end a connecting-piece or opening for the introduction of the contrast medium. The outlet openings have an entry tg the ureter which can be direct or via the front-side or front-face opening of the upper (distal) tip of the ureter tube. In one embodiment of this invention the upper (distal) outlet opening (23;9) of the mandrin (21) or inner mandrin (4) is formed by the upper (distal) tip (22;4b) of the mandrin and is in the insertion position flush to or slightly below the front-side opening (11) of the upper (distal) tip of the ureter tube. Mandrin and inner mandrin of the arrangement are preferably a metal tube or plastic tube. In a preferred arrangement of this invention, the ureter tube and mandrin resp. outer mandrin are in a configuration for insertion in that they are releasably but firmly connected. They can be clamped together in the (proximal) end section of the [auxiliary] ureter tube. The term "insertion position" [in the preamble of claim 2] shall mean the configuration of the ureter tube, mandrin and auxiliary tube relative to each other during the insertion of the total arrangement into the ureter and also during the introduction of an X-ray contrast media. Such a releasable connection between the mandrin resp. outer mandrin and ureter tube is described in the German Patent Application DE-OS 3,900,738 filed by the Applicant. After additional use of a clamping connection for the mandrin resp. outer mandrin at the (proximal) end section of the auxiliary tube, the ureter tube, the mandrin resp. double mandrin and the auxiliary tube form a functional unit. For facilitating the insertion the functional unit allows forward, backward and rotational movements of the ureter tube and of the curvatures of the tip of the ureter tube and allows after proper positioning of the ureter tube an easy removal of the mandrin and auxiliary tube. The disclosure of German Patent Application DE-OS 3,900,738 is incorporated herewith by reference, in particular with respect to the therein described different possibilities for a releasable connection between ureter tube and mandrin resp. outer mandrin like the clamping by means of a thickening of the mandrin resp. outer mandrin which increase the diameter (there claims 4, 5 and 6 and FIGS. 2, 3 and 4), or of the ureter tube (there claims 1 and 2 and FIG. 1) or by using an insert between the mandrin resp. outer mandrin and the ureter tube (there claim 8 and FIGS. 7 and 8) in such a way that when setting the arrangement in the insertion configuration, the ureter tube and the mandrin resp. outer mandrin are connected by clamping. The clamping or friction between mandrin resp. outer mandrin and ureter tube can be released by pulling the mandrin resp. outer mandrin in a longitudinal direction while at the same time the auxiliary tube avoids movement of the ureter tube. The mentioned friction can be increased by roughening the surfaces or providing them with grooves. A releasable connection between mandrin resp. outer mandrin and ureter tube is also possible by the use of a releasable screwing as described in the German Patent Application DE-OS 3,824,244 the disclosure whereof is also incorporated herewith by reference. The releasable screwing gives a functional unit of the two parts allowing said rotational, forward and backward movements of the arrangement.
It is a further object to improve the [arrangement of the preamble of claim 2] known arrangements for the insertion of a ureter tube in such a way that more functions are given to the mandrin, in particular to use it for a simpler and less expensive introduction of X-ray contrast media.
These further objects can be achieved by an arrangement [according to claim 2] comprising ureter tube, auxiliary tube and mandrin like a double mandrin and having the above described characteristics of the arrangement according to this invention. The cylindrical hollow-space inside of the inner mandrin resp. mandrin forms a passage for an X-ray contrast medium from the inlet opening of the mandrin, positioned outside of the body, to the ureter. This results in some advantages. The cylindrical hollow-space inside of the inner mandrin resp. mandrin has a relatively large cross-section and thereby enables the fast passage of a sufficient amount of X-ray contrast medium to the ureter respectively to the renal pelvis under relatively low pressures. There is no need to pull out the inner mandrin from the ureter tube for the transport of an X-ray contrast medium to the ureter, the inner mandrin can stay in its insertion position. Hence, the surgeon saves valuable time. Furthermore, in a preferred embodiment, it is possible to move the arrangement of ureter tube, mandrin and auxiliary tube and to bring the tip of the ureter tube into the final position in the renal pelvis during the introduction of an X-ray contrast media to the ureter. If necessary, there is also the possibility to move the inner mandrin resp. mandrin relative to the ureter tube. By pulling back the inner mandrin resp. mandrin, the inherent curvature of the tip of the ureter tube will be no more straightened, thereby allowing the curvature of the tip of the ureter tube to adapt, if necessary, to the curvature of the ureter. Other advantage are very important for the physician because the ureter and the renal pelvis can be examined and the ureter tube can simultaneously be moved. This is especially important for the proper positioning of the curved tip of the ureter tube within the renal pelvis.
[The preferred embodiment of the invention given in claim 3 allows] In a preferred embodiment of this invention where the upper (distal) outlet opening (23,9) of the mandrin (21) or inner mandrin (4) is formed by the distal tip (22;4b) of the mandrin (21) or inner mandrin (4) and where in the insertion position the opening is flush to or slightly below the front-side opening (11) of the upper (distal) tip (12) of the ureter tube, the hollow-space (10) of the ureter tube forms a passage of the X-ray contrast medium from the outlet opening (23;9) of the tip (22) of the mandrin or of the tip of the inner mandrin (4b) to the opening (11) of the tip (12) of the ureter tube. Such arrangement allows an optimal straight-line flow of an X-ray contrast medium from the inlet of the medium to the ureter.
[An alternative embodiment of the invention, according to claims 4, 5 and 6, show further possibilities of the position of the upper outlet opening or openings.]
[The embodiment of the invention according to claim 7 offers the further] In another embodiment of the invention the inner mandrin (4) or mandrin (21) projects above the front-side opening of the upper (distal) tip of the ureter tube in the insertion position and has in such upper (distal) end of the mandrin or inner mandrin an inherent curvature or memory. Such arrangement has a steering wire (18) in the hollow-space (8) inside of the inner mandrin (4) or mandrin (21) which is essentially stiff against bending and movable in the longitudinal direction. Preferably the upper (distal) tip of the inner mandrin can be closed against passage of the steering wire and against passage of the X-ray contrast medium. It is an advantage to provide also the upper section of the inner mandrin resp. mandrin with an inherent curvature, sometimes also called "memory". Such an inherent curvature is in particular known for the tip of the ureter tube where the curvature can be straightened by use of the mandrin during the insertion of the ureter tube. After having reached the final position, in which the upper tip of the ureter tube is in the renal pelvis and its lower tip is in the bladder, the mandrin is pulled out. The tips of the ureter tube then take the shape of its inherent curvature which keep themselves at the inner wall of the bladder or in the renal pelvis thereby avoiding migration. A similar inherent curvature in the tip area of the mandrin, which essentially surpasses the tip of the ureter tube, is possible too. Here it is an advantage that a special steering wire of the inner mandrin resp. mandrin compensates the inherent curvature and thus effects a straightening of the tip of the inner mandrin resp. mandrin. Such tip of the inner mandrin resp. mandrin which surpasses the tip of the ureter tube can have a variable inherent curvature and can easily bypass obstructions, pass narrow passages and follow twisty courses of the ureter and make its way to the renal pelvis much easier than the thicker tip of the ureter tube. The ureter tube being thicker than the inner mandrin resp. mandrin can then follow the prepared way.
Further advantages and characteristics of the present invention can be seen in or easily derived from [the claims, from] the following description and from the drawings relating thereto.